Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea

Официальное название

Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea: a Multicenter Randomized Controlled Trial

Обзор

Chronic Obstructive pulmonary Disease (COPD) is a common progressive disorder characterized by persistent airflow limitation. It is usually caused by exposure to tobacco smoke, toxic particles, or toxic gases. COPD is characterized by cough, sputum production, and dyspnea, which is the cardinal symptom and is included in the criteria for severity. Dyspnea is a major source of suffering and disability, especially when it persists at rest. Despite proper medical treatment, many patients continue to suffer from persistent dyspnea that significantly impairs their daily functioning and quality of life. Complementary approaches such as yoga and relaxation techniques are therefore recommended by some experts. Hypnosis is one of these practices. It has been shown to be effective in the management of both acute and chronic pain and it can abolish several types of experimentally induced dyspnea in healthy volunteers. In adults with COPD, a single hypnosis session has been shown to reduce anxiety immediately, though only temporarily. However, according to a recent retrospective study, a median of three hypnosis sessions increases the distance covered in the 6-minute walk test in COPD patients. The investigators therefore hypothesize that several hypnosis sessions will improve the quality of life of adult outpatients with COPD who suffer from persistent dyspnea. The study plans to recruit 154 patients with severe dyspnea (mMRC(modified Medical Research Council Dyspnea Scale) 3 or 4). They will be randomly assigned to either the experimental group or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The primary outcome of the study will be the evolution of quality of life, assessed 6 weeks after the start of the study as compared to baseline. Secondary outcomes will focus on changes in exercise capacity, dyspnea, anxiety, depression, dyspnea-related catastrophizing, self-efficacy, and pleasure in life.

Подробное описание

The study aims at assessing the effect of medical hypnosis on the quality of life of dyspneic COPD outpatients. It plans to recruit 154 COPD outpatients with severe dyspnea (mMRC 3 or 4). They will have to be treated in accordance with the GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2024 guidelines, exept for pulmonary rehabilitation that is not required. Inclusion and non-inclusion criteria are provided below. Patients will be randomly assigned to either the experimental or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The objectives of the study will be assessed 6 weeks after enrollment. The primary objective of this study will be to evaluate the benefit of hypnosis in improving the quality of life of outpatients with COPD and persistent dyspnea, compared to a control group that will receive support through standardized telephone calls but no hypnosis.

The primary outcome will be the change in the total score of the St George's Respiratory Questionnaire (SGRQ) which assesses respiratory related quality of life, measured 6 weeks after randomization.

The secondary objectives of the study will be to evaluate the benefit of hypnosis in patients with COPD and persistent dyspnea compared to the control group on the following outcomes:

1. The components of quality of life in COPD: symptoms, activity, and impact on daily life. Those components are part of the SGRQ. 2. The ability to engage in physical activity. It will will be assessed with the 6-min walk test. 3. Dyspnea and its affective, sensory, and emotional dimensions. They will be assessed using the multidimensional dypnea profile (MDP) questionnaire. d) Dyspnea in activities of daily living. It will be assessed using the London Chest Activity of Daily Living (LCADL) scale.

e) The level of anxiety. It will be assessed using the Hospital Anxiety and Depression Scale (HADS).

f) The level of depression. It will also be assessed using the Hospital Anxiety and Depression Scale (HADS).

g) The level of catastrophizing about dyspnea. It will be assessed using the breathlessness catastrophizing scale for chronic obstructive pulmonary disease.

h) The level of self-efficacy. It will be assessed using the COPD Self-Efficacy Scale.

i) The level of pleasure (or the level of anhedonia). It will be assessed using the Snaith-Hamilton Pleasure Scale.

Вмешательства

• Поведенческое Hypnosis
  Five medical hypnosis sessions, each scheduled 7 ± 2 days apart
• Другое standardized telephone calls
  Four standardized telephone calls, made at 7 ± 2 day intervals

Первичные конечные точки

• Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ) [Срок оценки: 6 weeks]

Вторичные конечные точки (8)

• Change in the three component scores of the SGRQ that assess the quality of life in COPD in terms of symptoms, activity and impact on daily life [Срок оценки: 6 weeks]
• Change in ability to engage in physical activity [Срок оценки: 6 weeks]
• Change in dyspnea and its affective, sensory, and emotional dimensions [Срок оценки: 6 weeks]
• Change in dyspnea in activities of daily living [Срок оценки: 6 weeks]
• Changes in levels of anxiety and depression [Срок оценки: 6 weeks]
• Change in level of catastrophizing about dyspnea [Срок оценки: 6 weeks]
• Change in level of self-efficacy in COPD [Срок оценки: 6 Weeks]
• Change in level of pleasure (or the level of anhedonia) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Age >18 years
• COPD (any etiology), referred by a pulmonologist and managed according to GOLD 2024 guidelines except for pulmonary rehabilitation that is not required
• Outpatient follow-up
• Residing in Paris or the inner suburbs for centers located within the city limits, or within a 30-minute drive for centers located outside the city limits of Paris.
• Dyspnea rated as mMRC 3 or 4
• Having signed an informed consent form

Критерии исключения

• Vulnerable individuals (under legal guardianship or curatorship) or deprived of liberty
• Pregnant or breastfeeding women
• Absolute or relative contraindication to the 6 minutes walk test, spirometry or body plethysmography
• Current COPD exacerbation or exacerbation resolved less than one week ago
• Psychosis or other psychiatric disorder likely to interfere with study participation
• Profound hearing impairment
• Cognitive impairment
• Use of psychedelic substances (ex: LSD (Lysergic acid diethylamide), psilocybin, etc.)
• Current participation in interventions that may be related to hypnosis: any kind of meditation, relaxation, sophrology, heart coherence training, yoga, Qi Gong, holotropic breathing, EMDR (Eye Movement Desensitization and Reprocessing) or any psychotherapies involving eye movements, as well as shamanic practices and brief psychotherapies or cognitive-behavioral therapies
• Previous management of dyspnea using hypnosis
• Ongoing pulmonary rehabilitation (physiotherapy outside a structured rehabilitation program initiated before study inclusion is not an exclusion criterion)
• Inability to be reached by phone or teleconsultation
• Lack of health insurance (French social security) coverage
• Participation in another clinical trial
• End of life

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• APHP, Hôpital Pitié-Salpêtrière — Paris

Идентификаторы

NCT: NCT07637604 · APHP251231 · N° IDRCB: 2025-A02601-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗